Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

An Open, Dose Escalation, Single Dose Study to Assess Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02291471

Enrollment

Registered

2014-11-14

Start date

2014-10-31

Completion date

2015-02-28

Last updated

2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatic Diseases

Brief summary

The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers.

Interventions

DRUGT0001，10mg

DRUGT0001，20mg

DRUGT0001，35mg

DRUGT0001，50mg

DRUGT0001，65mg

DRUGT0001，75mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adult volunteers, able to give written informed consent for participation in the trial; * Men or women 50% each , aged 18-45 years old; * Subjects must have physical examination required and prove medical fitness in 7 days before the clinical starts. BMI should be between 19-24, similar BMI among subjects enrolled at the same time;

Exclusion criteria

* Acute or chronic infection, or history of active tuberculosis; * History of diseases of central nervous system, cardiovascular system, kidney, liver ( specified liver function index), digestive system, respiratory system , metabolism system; * Subjects who use 5 Unit doses tuberculin skin test are positive( 48-72 hour scleroma reading≥5mm); * Subjects with a history of mental problems; * Pregnant and lactating women or women who plan to be pregnant in 3 months; * Occurence of clinical significant abnormal laboratory examination value during the screening; * Subjects that lack of understanding ,communication or collaboration, and can't comply with the protocols; * Subjects that the researchers considered to be not appropriate to participate the trial due to other reasons;

Design outcomes

Primary

Measure	Time frame
Maximum Tolerance Dose	3 weeks

Secondary

Measure	Time frame
Adverse events	3 weeks
pharmacokinetics parameter(Cmax, AUC, t1/2, CL, etc）	Pre-dose，2、4、12、24、36、48、60、72、84、96、120、144、168、216、264、312、384 and 480hours after the start of subcutaneous injection

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026